Status:
COMPLETED
Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease
Lead Sponsor:
Alzheon Inc.
Conditions:
Early Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include...
Detailed Description
The LTE year 1 \& 2 study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of LT...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age between 50 and 80 years, inclusive.
- Early Alzheimer's Disease (AD): a diagnosis of Probable AD Dementia or Mild Cognitive Impairment (MCI) due to AD in accordance with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria \[Albert et al, 2011; McKhann et al, 2011\].
- One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous).
- MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0, and CDR Memory Box Score of ≥ 0.5.
- Documented confirmation of AD diagnosis by either positive amyloid positron emission tomography (PET) or positive CSF AD signature. Subjects without documented positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening.
- Stable doses of acetylcholinesterase for the duration of the study are allowed.
- Exclusion Criteria
- Brain MRI at screening indicative of significant abnormality
- Diagnosis of neurodegenerative disorder other than AD
- Current diagnosis of Major Depressive Disorder (MDD)
- Concomitant treatment with memantine.
Exclusion
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04693520
Start Date
September 30 2020
End Date
July 16 2025
Last Update
December 18 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Anne's University Hospital
Brno, Czechia
2
Motol University Hospital
Prague, Czechia
3
Vestra Clinics
Rychnov nad Kněžnou, Czechia
4
Brain Research Center
's-Hertogenbosch, Netherlands